PHARMA TECH

Milestone Scientific Names Andau Medical as an Additional Distributor for the STA Single Tooth Anesthesia System® in North America

Milestone Scientific, Inc. | December 24, 2021

Milestone Scientific Inc. a leading developer of computerized drug delivery instruments, that provide painless and precise injections, announced it has entered into an agreement with Andau Medical to distribute the STA Single Tooth Anesthesia System® in the United States and Canada.

Arjan Haverhals, CEO of Milestone Scientific, stated, “We are pleased to announce the addition of Andau Medical to our growing roster of distributors for the STA Single Tooth Anesthesia System in the United States and Canada. We initially began our collaboration with Andau around our CompuFlo® Epidural Instrument in Canada. In addition to medical devices, they have a strong track record introducing dental instruments to the market, which we believe will help further fuel the strong momentum we’re experiencing within our dental division.”

 “We are excited to expand our existing partnership with Milestone Scientific by introducing the STA Single Tooth Anesthesia System through our broad network of dentists and hygienists across North America. The STA offers significant benefits to both patients and clinicians through painless injections, shorter wait times for anesthesia, fewer complications, and reduced patient cancellations.   This enables dentists to grow their businesses while improving the patient experience.”

Sandi Wright, Founder and CEO of Andau Medical

About Andau Medical
Andau Medical is a Medical Device and Dental Device company focused on providing U.S. and Canadian markets with quality technologies that improve patient outcomes and enhance the clinical experience in delivering exceptional patient care. Andau has expertise in sales, marketing, regulatory and distribution, thereby enabling quick market uptake of both existing and new technologies.

About Milestone Scientific Inc.
Milestone Scientific Inc. a technology focused medical research and development company that patents, designs and develops innovative injection technologies and instruments for medical, dental and cosmetic applications. Milestone Scientific’s computer-controlled systems are designed to make injections precise, efficient and increase the overall patient comfort and safety. Their proprietary DPS Dynamic Pressure Sensing Technology® instruments is the platform to advance the development of next-generation devices, regulating flow rate and monitoring pressure from the tip of the needle, through platform extensions of subcutaneous drug delivery, including local anesthetic. 

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Veneno Technologies, a Novel DRP Drug Discovery Company, Raises $2Million (¥200M Yen) in Seed Funding Round

Veneno Technologies Co. Ltd. | January 27, 2022

Veneno Technologies Co. Ltd. is pleased to announce that it has completed fundraising of 200 million yen through a third-party allocation of new shares to SBI Investment Co., Ltd., Tsukuba Institute of Research, Ltd., and SBI regional activation support Co., Ltd. The funds raised will be used to strengthen the recruitment and organizational structure, to further develop the Company's proprietary peptide drug discovery platform technology, and invest in the research and development of the Company's own drug discovery pipeline using DRP functional peptides as basic molecules to further promote DRP drug discovery. Objective of the Fund Procurement Veneno Suite™ is the Company's proprietary integrated DRP drug discovery technology. The Veneno Suite™ consists of a large gene library that is created by artificially accelerating the evolution of natural DRPs using them as templates, a screening system that enables the search for target DRPs from the library in a fast and efficient manner, and technology that enables the efficient production of various DRPs in a short period of time. With this funding, we will further refine these technologies and accelerate DRP drug discovery. Our mission is to contribute to the advancement of medicine by providing new drugs for targets such as membrane proteins that have been difficult to discover, and for intractable diseases related to these targets. In order to fulfill this mission, we will strengthen the following points through this fundraising. Appointment of high-level researchers and opening of new laboratories to advance DRP drug discovery. Expansion of the DRP focused library (DRP Space™). Strengthen and expand the pipeline of the DRP rapid search system (PERISS™) (promote joint research). Development of DRP manufacturing technology (Super Secrete™) including establishment of high-efficiency, low-volume, high-mix manufacturing technology. This funding will enable us to further refine our proprietary large-scale library, high-speed screening technology, and high-efficiency DRP manufacturing technology to accelerate our goal of DRP drug discovery. We expect that we will be able to take a concrete step toward the establishment of a new paradigm using DRP as a new drug discovery platform molecule following antibody drugs. Investor Comments Mr. Makoto Hasegawa, Manager, Investment Division, SBI Investment Co. noted, "Veneno Technologies has developed an innovative technology to turn functional peptides, called DRPs, into pharmaceuticals. We have decided to invest in Veneno Technologies because we see the potential in their technology and want to take on the challenge of developing new modalities together. We hope that our technology will lead to the development of many innovative new drugs in the future." "Veneno Technologies is a drug discovery venture that uses this technology to develop drugs that target ion channels, which remain untapped as drug targets." Mr. Masato Suzuki, Senior Researcher, Consulting Department, Tsukuba Research Institute, Inc About Veneno Technologies, Inc. Veneno Technologies was established to accelerate the research and development of DRP functional peptides and to contribute to advanced and sustainable medicine and society. The company was established to accelerate the research and development of DRP functional peptides and to contribute to advanced and sustainable medicine and society. By integrating innovative DRP discovery technologies that have been researched for many years at the National Institute of Advanced Industrial Science and Technology (AIST) and DRP manufacturing technologies that are currently being researched and developed, we will lead the research and development of various DRP drug discovery technologies such as new drugs, research reagents, agrochemicals and biostimulants.

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BUSINESS INSIGHTS

Long Island University Extends Partnership with Dassault Systèmes to Innovation and Research in Life Sciences

Long Island University | March 23, 2022

Long Island University announced a new research and innovation partnership with Dassault Systèmes in life sciences. The partnership will focus on research with high societal impact to advance the fields of pharmaceutical sciences, precision medicine and health care in the digital age. Research includes precision medicine using "Virtual Twins," or exact digital models of human anatomy being developed by LIU and Dassault Systèmes; pandemic preparedness and the digitization of healthcare; innovation in medical devices; and telemedicine through the "Internet of Things," or the exchange and analysis of data between physical objects that are connected digitally. In addition, the partnership aims to provide a platform for technology transfer, or the sharing and transformation of inventions and scientific outcomes into commercialized products or services that benefit society. "Long Island University is at the forefront of revolutionizing health care training and research in higher education with our ongoing partnership with Dassault Systèmes. We are investing in opportunities and technology to ensure our students become future leaders and innovators in emerging industries." President Kimberly R. Cline As part of this commitment to students, LIU has also been designated as a Dassault Systèmes 3DEXPERIENCE Edu Center of Excellence. Dassault Systèmes created the global 3DEXPERIENCE Edu Centers of Excellence program in October 2021. The program is aimed at providing students, professionals, learners, businesses and governments with a network of centers dedicated to experiential, lifelong learning with its 3DEXPERIENCE platform that enables the current and future workforce to accelerate the digital transformation of industry. "At Dassault Systèmes, we have the profound belief that the virtual world extends and improves the real world helping to address today's social and environmental challenges," said Rama Kondru, Ph.D. co-CEO of Medidata, a Dassault Systèmes company. "This strategic initiative with LIU brings enormous opportunities since it is helping to prepare the next generation of life science experts to innovate in tomorrow's more sustainable economy, transform healthcare, and solve some of the biggest medical challenges in areas such as cancer and Alzheimer's disease." LIU is the second Center of Excellence in the U.S. in addition to Purdue University, which opened as a Center of Excellence in Advanced Composites in 2020. Additional centers have been established in France, Mexico, Germany, Switzerland, Brazil and India, and focus on various industry sectors. "Earning the distinction of being named a 3DEXPERIENCE Edu Center of Excellence is a testament to Long Island University's standing as a preeminent academic institution," said LIU Board of Trustees Chair Eric Krasnoff. "We are proud to partner with Dassault Systèmes to create an ecosystem where students, faculty and industry partners can collaborate on real-world, impactful learning." The University's extended and ongoing partnership with Dassault Systèmes, world leader in 3D design and engineering software, is in line with its vision to advance academic excellence through innovation, provide extraordinary and distinctive experiences to students, and create solutions for a sustainable global future. Forged in 2019, the partnership provides LIU students with hands-on experience using cutting-edge artificial intelligence and digital engineering technologies, and to collaborate on multidisciplinary research in the life sciences. "The LIU-Dassault Systèmes research partnership is centered on solving real-world problems through an integrated approach to education while simultaneously developing the future workforce for precision medicine, healthcare and pharmacy," said Dr. Randy Burd, senior vice president for academic affairs at LIU. "We look forward to using Dassault Systèmes' incredible technology to expand and enhance life sciences, liberal arts, humanities and performing arts degree programs throughout the University." In 2021, the University opened a state-of-the-art simulation laboratory that allows students to use Dassault Systèmes' patented 3D, augmented reality and virtual reality software to conduct experiential research, education and training. The laboratory is used in several areas of study, including artificial intelligence, robotics, virtual reality gaming, cybersecurity, data analytics, and drug discovery and development. LIU also employs Dassault Systèmes' cloud-based 3DEXPERIENCE platform in classrooms across the University. "LIU has entered a truly transformative niche in higher education by aligning with a digital healthcare industry that is on the rise," said Dr. Mohammed Cherkaoui, vice president for academic affairs at LIU. "We are honored to work with Dassault Systèmes, combining its content expertise and research tools to become a global leader in the innovation of healthcare." About Long Island University Long Island University, founded in 1926, continues to redefine higher education, providing high quality academic instruction by world-class faculty. Recognized by Forbes for its emphasis on experiential learning and by

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PHARMA TECH

n-Lorem Foundation Partners with Alnylam to Expand Technology Access to RNAi Therapeutics for Patients with Nano-rare Diseases

n-Lorem a nonprofit Foundation | January 20, 2022

n-Lorem, a nonprofit Foundation, discovering and providing experimental antisense oligonucleotide medicines to nano-rare disease patients for free, for life, today announced a new partnership with Alnylam Pharmaceuticals Inc. “Discovering, developing and providing individualized medicines for nano-rare patients is a monumental task. At n-Lorem, using ASO technology, we take advantage of three decades of experience, unparalleled quality control and integrated safety databases that are used to select frequency and dosage for each individual ASO therapy. As we expand our highly selective and versatile model to other amendable technologies, it is important for us to maintain a high level of quality,” said Stanley T. Crooke, M.D., Ph.D., Founder, Chief Executive Officer and Chairman, n-Lorem Foundation. “Alnylam’s RNAi therapeutic technology is the perfect complement to Ionis’ ASO technology, both are well understood, proven drug discovery technologies. Adding Alnylam as a partner is another step in the creation of a broad network of partner stakeholders committed to treating nano-rare patients.” “We are pleased to partner with the n-Lorem Foundation in identifying opportunities to bring our novel RNAi technology platform to potentially help patients with nano-rare diseases. At Alnylam, we are committed to identifying pathways to expand access to our medicines and we applaud the work of the foundation in bringing together industry partners who are driven to provide options for patients that have little or no options for treatment,” Akshay Vaishnaw, M.D., Ph.D., President at Alnylam “Although we have the tools and expertise to understand nano-rare patients at a genetic level, the extreme rarity of these patients present insurmountable challenges to the current healthcare systems,” said Dr. Sarah Glass, Chief Development Officer, n-Lorem Foundation. “n-Lorem is addressing these challenges one nano-rare patient at a time and is supported through a consortium of well-renowned and diverse organizations worldwide. These include our biotechnology and pharmaceutical partners, including Ionis Pharmaceuticals, Biogen, Ultragenyx and today Alnylam; our clinical research partners, including Charles River Labs, Korea Institute of Toxicology and Parexel; our contract manufacturing partners, including ChemGenes, Cytiva and Nitto Avecia; and many other collaborations that make n-Lorem’s mission possible.” Alnylam is leading the translation of RNA interference into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare genetic, cardio-metabolic, hepatic infectious, and central nervous system ocular diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach for the treatment of a wide range of severe and debilitating diseases. Founded in 2002, Alnylam is delivering on a bold vision to turn scientific possibility into reality, with a robust RNAi therapeutics platform. Alnylam’s commercial RNAi therapeutic products are ONPATTRO®, GIVLAARI® (givosiran), and OXLUMO®, as well as Leqvio®, which is being developed and commercialized by Alnylam’s partner Novartis. Alnylam has a deep pipeline of investigational medicines, including six product candidates that are in late-stage development. Alnylam is executing on its “Alnylam P5x25” strategy to deliver transformative medicines in both rare and common diseases benefiting patients around the world through sustainable innovation and exceptional financial performance, resulting in a leading biotech profile. Alnylam is headquartered in Cambridge, MA. About n-Lorem n-Lorem Foundation is a non-profit organization established to apply the efficiency, versatility and specificity of antisense technology to charitably provide experimental antisense oligonucleotide medicines to treat nano-rare patients diagnosed with diseases that are the result of a single genetic defect unique to only one or very few individuals. Nano-rare patients describe a very small group of patients who, because of their small numbers, have few if any treatment options. n-Lorem Foundation was created to provide hope to these nano-rare patients by developing individualized ASO medicines, which are short strands of modified DNA that can specifically target the transcripts of a defective gene to correct the abnormality. The advantage of experimental ASO medicines is that they can be developed rapidly, inexpensively and are highly specific. To date, n-Lorem has assisted in the development and treatment of 14 nano-rare patients and received over 100 applications for treatment with more than 40 nano-rare patients approved. n-Lorem was founded by Stanley T. Crooke, M.D., Ph.D., former chairman and CEO of Ionis Pharmaceuticals, who founded Ionis Pharmaceuticals in 1989 and, through his vision and leadership, established the company as the leader in RNA-targeted therapeutics.

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Telix Pharmaceuticals Announces Licence Agreement with Lilly for Olaratumab

Telix Pharmaceuticals Limited | April 11, 2022

Telix Pharmaceuticals Limited announces that it has entered into a licence agreement with Eli Lilly and Company under which Telix is granted exclusive worldwide rights to develop and commercialise radiolabelled forms of Lilly's olaratumab antibody for the diagnosis and treatment of human cancers. Telix's initial development focus will be on a rare type of cancer known as soft tissue sarcoma. Olaratumab was originally developed by Lilly as a monoclonal antibody targeting Platelet Derived Growth Factor Receptor Alpha. PDGFRα is expressed in multiple tumour types including STS. STS is generally a radiation susceptible cancer that may be inherently amenable to systemic radionuclide therapy and olaratumab's ability to target PDGFRα makes it a highly novel and potentially exciting candidate for use as a radionuclide targeting agent. The exclusive worldwide licence will allow Telix to repurpose olaratumab as a targeting agent for radiopharmaceutical imaging and therapy of cancer. Olaratumab has an established safety profile that underpins its potential use as a radionuclide targeting agent. Material terms of the agreement Under the terms of the agreement Telix will pay Lilly an upfront payment of US$5M for the grant of an exclusive licence to Lilly's intellectual property related to the development of a radiolabelled olaratumab, as well as access to material for use by Telix in initial pre-clinical and early-phase clinical studies in application to potential uses for the diagnosis and treatment of human cancers. Lilly may be eligible for up to US$225M in payments based upon the achievement of pre-specified development, regulatory and commercial milestones. Lilly would also be eligible to receive industry standard royalties on net sales. The agreement also includes an option for Lilly to be granted an exclusive licence to a radiolabelled companion diagnostic which would be developed by Telix. If exercised, Lilly will pay Telix US$5M and up to US$30M in potential development milestones, as well as industry standard royalties. The agreement has typical termination rights for breach and related corporate issues. Telix retains termination rights typical to licence agreements of this nature to enable the Company to exit the agreement based on a development or commercial basis. "This in-licence transaction with Lilly is a valuable – and rare – opportunity to acquire an asset which has demonstrated clinical safety. In our pre-transaction diligence and research, we have identified that a radiolabelled version of olaratumab could be efficacious in patients with STS, particularly as it is a highly radiation-sensitive cancer. The safety data generated by Lilly in relation to the original development program significantly de-risks the program for Telix. We anticipate that early clinical translation with a radiolabeled olaratumab as an imaging agent may also provide valuable clinical information as to whether this asset has potential therapeutic efficacy, demonstrating the advantage of Telix's "theranostic" approach. Telix Group CEO and Managing Director, Dr. Christian Behrenbruch "This acquisition mirrors the approach that Telix has taken in building its existing pipeline by in-licencing or acquiring assets that have already been proven to be safe for use in humans that can be harnessed as novel radiolabelled targeting agents. This partnership also demonstrates the value that Telix can bring as a capable partner with the expertise in radiopharmaceutical development and manufacturing, to help repurpose or expand the use of promising candidates to better target, find and treat cancer." About Soft Tissue Sarcoma Soft tissue sarcoma is a complex disease that encompasses a diverse group of relatively rare cancers, with more than 50 histological subtypes. In the United States, it is estimated that 13,040 new cases and 5,150 deaths were caused by STS in 2019, representing 0.75% of overall cancer incidence and 0.84% of overall cancer mortality.1 In Europe, nearly 23,600 new STS cases rose annually, and the crude incidence rate was 4.7 per 100,000.2 Approximately 39,900 new STS cases occurred nationwide in China in 2019, accounting for 1.05% of overall cancer incidence.3 The crude incidence rate was 2.91/100,000 and generally increased with age. Standard treatment for soft tissue sarcoma includes surgery, radiation therapy and/or chemotherapy. For patients with advanced, unresectable, or metastatic disease, treatment typically involves chemotherapy with single agents or anthracycline-based combination regimens. However, the prognosis for these patients remains poor, with treated patients with metastatic disease having a median overall survival of around 12–18 months. About olaratumab Olaratumab was originally developed as a monoclonal antibody targeting PDGFRα. Olaratumab was granted "Accelerated Approval" in the US and "Conditional Approval" in the EU based on Phase 2 trial data which showed a 1-year survival benefit in patients with STS, when given in combination with standard chemotherapy. Olaratumab was voluntarily withdrawn from the market by Lilly following the failure of the Phase 3 ANNOUNCE clinical trial, in which olaratumab did not improve survival for patients. About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic products using Molecularly Targeted Radiation. Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan, Switzerland, and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange.

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